CD80 and CD86 binding protein compositions and uses thereof

Abstract

This invention relates to CTLA-4 protein compositions and their use in the mitigation of autoimmune adverse events associated with cancer immunotherapy.

The invention claimed is: 
     
       1. A method of treating adverse events associated with a cancer immunotherapy in a subject in need thereof, comprising administering to the subject a CTLA-4 protein, wherein the CTLA-4 protein comprises an extracellular domain of CTLA-4 comprising the sequence set forth in SEQ ID NO: 38, and wherein the cancer immunotherapy comprises Ipilimumab or Tremelimumab. 
     
     
       2. The method of  claim 1 , wherein the extracellular domain of CTLA-4 is fused at its C-terminus to a Fc region of a human immunoglobulin protein selected from the group consisting of IgG1, IgG4, and IgM. 
     
     
       3. The method of  claim 2 , wherein the CTLA-4 protein comprises the sequence set forth in SEQ ID NO: 21. 
     
     
       4. The method of  claim 1 , wherein the CTLA-4 protein is present at a therapeutically effective amount in a pharmaceutical composition comprising a physiologically acceptable carrier or excipient. 
     
     
       5. The method of  claim 1 , wherein the cancer immunotherapy is Tremelimumab. 
     
     
       6. The method of  claim 1 , wherein the anti-CTLA-4 antibody is Ipilimumab. 
     
     
       7. The method of  claim 1 , wherein the cancer immunotherapy further comprises an anti-PD-1 antibody. 
     
     
       8. The method of  claim 1 , wherein the subject has cancer. 
     
     
       9. The method of  claim 3 , wherein the subject has cancer. 
     
     
       10. The method of  claim 6 , wherein the subject has cancer. 
     
     
       11. A method of treating adverse events associated with a cancer immunotherapy in a subject in need thereof, comprising administering to the subject a CTLA-4 protein, wherein the amino acid sequence of the CTLA-4 protein consists of the sequence set forth in SEQ ID NO: 21, and wherein the cancer immunotherapy comprises Ipilimumab or Tremelimumab. 
     
     
       12. The method of  claim 11 , wherein the CTLA-4 protein is present at a therapeutically effective amount in a pharmaceutical composition comprising a physiologically acceptable carrier or excipient. 
     
     
       13. The method of  claim 11 , wherein the cancer immunotherapy is Tremelimumab. 
     
     
       14. The method of  claim 11 , wherein the anti-CTLA-4 antibody is Ipilimumab. 
     
     
       15. The method of  claim 14 , wherein the cancer immunotherapy further comprises an anti-PD-1 antibody. 
     
     
       16. The method of  claim 11 , wherein the subject has cancer. 
     
     
       17. The method of  claim 14 , wherein the subject has cancer.